BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3013472 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02877
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PRIME HISTORY RECORDED SEVERAL LARGE PRIMES. ATTEMPTED TO REWIND AND LOAD BUT RECEIVED A NO CARTRIDGE DETECTED ALARM. FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATION LOW. REMOVED FORCE SENSOR FROM MOTOR ASSEMBLY. FORCE SENSOR PLATE WAS CONTAMINATED WITH A GREEN SUBSTANCE. FORCE SENSOR PLATE RESISTANCE READING OUT OF SPECIFICATION. FORCE SENSOR HIGH. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED THE FORCE SENSOR TO BE CONTAMINATED AND OUT OF CALIBRATION. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116493 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR